A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Danning Tablet.
- Кому может быть актуально
- Состояния в реестре: Indigestion, Dyspepsia, Bloating, Loss of Appetite. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational study is to evaluate if Danning Tablets are effective in alleviating dyspepsia in patients with any of the following digestive symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation. The main questions it aims to answer are: How effective are Danning Tablets for patients with indigestion symptoms? What are the impact factors (e.g. severity of conditions, demographic features, dose and length of treatment etc.) of the efficacy of Danning Tablets for indigestion patients? Participants already taking Danning Tablets as part of their regular medical care for indigestion will take questionnaires by the end of two weeks and four weeks respectively from the start of their treatment.
Вмешательства
- Препарат Danning Tablet
Danning Tablet is the only exposure in this observational study.
Первичные конечные точки
- Dyspepsia symptoms responder rate post treatment [Срок оценки: From enrollment to the end of 4 weeks post enrollment]
Вторичные конечные точки (5)
- GPA responder rate [Срок оценки: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- GSRS score responder rate [Срок оценки: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Abdominal pain rating [Срок оценки: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Quality of Life assessment through EQ-5D-5L [Срок оценки: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Adverse event rate [Срок оценки: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
Критерии участия
Критерии включения
- Patients between 18 and 75 years old
- Patients with at least one of the following symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation
- Patients already taking Danning Tablets as part of their regular medicine treatment for dyspepsia
- Patients agree to sign the informed consent form
Критерии исключения
- Past history or comorbidity of malignant tumor
- Comorbidity of severe systemic condition including cardiovascular, cerebrovascular, renal and hematopoietic system diseases
- Past history of abdominal surgery (post pancreatic surgery, post subtotal gastrectomy; incomplete intestinal obstruction) or mental illness, mobility difficulty (e.g. long-term bed ridden)
- Comorbidity of any unstable chronic or acute disease,which may impact the evaluation of treatment efficacy as determined by the research physician
- Pregnancy or breastfeeding
- Participation in other clinical trials within the past 3 months
- Other circumstances determined as ineligible by the research physician
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу
Идентификаторы
NCT: NCT06755671 · CCPE202401